Good Documentation Practices FDA

Good documentation practices are essential to adhere to the regulations of the FDA. It is among the key GMP compliance components. Companies should practice good record-keeping to help them on regulatory inspections.            

Good Documentation Practices are guidelines that companies adapt in recording raw data entries in a traceable, legible, and reproducible way. The key to Good Documentation Practices is to ask questions:

  • Is it accurate?
  • Is it true? 
  • Is it legible?
  • Is it timely? 

FDA mandates all companies in the industry to document their products to meet the standards and legal requirements for efficacy, safety, and product quality. The following are the basics of GMP for good documentation practices. 

Data validation/ integrity 

  • True, genuine data
  • It needs to be relevant to the reporting requirement
  • Supported and validated/ witnessed vs. intentionally falsified
  • Not changeable after the entry of original record-keeping

Data accuracy 

  • Cross-checked for errors
  • Accurately recorded
  • Not intentionally misleading to avoid editable entries, fraudulent entries

Reporting/ record-keeping timeliness

  • Real-time record keeping like date stamps
  • Data is recorded synchronously
  • Avoid errors from memory issues and editing of original data

Legibility 

  • Legible (readable by anyone)
  • Clarity
  • Readily accessible

Identifiable 

  • Records which can identify the individual who records the data
  • Watch for new technology adaptations for GDocP as the systems change
  • Blockchain can be discussed as part of Pharma 4.0 innovations
  • Given growing concerns about cosmetic medicines and counterfeit pharmaceuticals and fake antibiotics and substandard medicines that enter global pharmaceutical chains
  • GDP and GMP mandate no shared passwords

Document types for Good Documentation Practices 

The following are some documents that need to follow Good Documentation Practices:

  • Logbooks
  • Protocols
  • Analytical methods
  • Certificate of Analyses (CoA)
  • Laboratory notebooks
  • Policies
  • Batch records
  • Standard operating procedures
  • Product and sample labels
  • Training documentation
  • Test methods and more

Document categories 

Primary records

These are obtained from packaging and manufacturing instructions and master formulas. 

Subsidiary records

These records support processes as it as carried out, like preventive maintenance/ calibration on lab equipment or process. It also includes environmental monitoring. 

Supporting procedures

It can include instructions for performing a test methodology or manufacturing step.

Quality control records 

These records involve lab testing results for the products or processes. It also includes investigative records and reports. 

Importance of documentation 

In the pharmaceutical market, it didn’t happen if it isn’t documented. So, documentation is essential in the pharmaceutical and medical device market to offer written proof of something that happened. 

Good documentation practices are important. It includes reports and records associated to production events that show the official documented record of:

  • Production of a device
  • Processing a batch
  • Final decision to release or reject a product or batch
  • Complaints or alleged product defects, investigation of manufacturing deviations
  • Evidence of preventive or corrective action
  • Meeting quality and product specifications generated from test results

Conclusion 

To sum it up, failure to comply with FDA Good Documentation Practices can be a FDA or TGA audit failure finding. All organizations in the industry should stay updated with the requirements and compliance monitoring with good documentation practices. These include contractors, employees, vendors, and distribution-chain personnel (transport drivers, warehouse employees, transportation, delivery, storage, packaging, and production workers).

Good documentation practices should also be implemented to maintain the good reputation of companies with their customers.  

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